(40 days)
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No
The summary describes a passive implant device and its surgical instruments, with no mention of AI or ML capabilities.
Yes
The device is intended to treat degenerative disc disease by providing mechanical support for intervertebral body fusion.
No
The device is an implant for intervertebral body fusion, used in the treatment of Degenerative Disc Disease, not for diagnosing it. Radiographic studies are mentioned as a way to confirm DDD, but the device itself is not used for diagnosis.
No
The device description explicitly states it is an intervertebral implant made of physical materials (PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum) and is provided sterile, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Duo™ Lumbar Interbody Fusion Device is an implantable medical device designed to provide mechanical support and aid in bone fusion in the lumbar spine. It is surgically implanted into the patient's body.
- Lack of In Vitro Testing: The description focuses on the device's physical properties, materials, and surgical use. There is no mention of testing biological samples or providing diagnostic information based on such tests.
- Input Imaging Modality: The input imaging modality is "Radiographic studies," which are used to visualize the spine and assess the condition, not to perform in vitro diagnostic tests.
Therefore, the Duo™ Lumbar Interbody Fusion Device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The Duo™ Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum. The Duo implant is available in varying lengths and heights with two lordotic configurations, and is provided sterile. The device is designed with a porous central cavity for graft containment, rounded nose to aid implant insertion, and ridged teeth to resist migration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lumbar spine from L2 to L5
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Duo Surgical Instrumentation: Where applicable, verification testing was performed to support modifications to the Duo surgical instrumentation.
- A review of the design changes to the Duo surgical instrumentation was performed and confirmed that these modifications do not present new technological characteristics or alter the intended use of these devices.
- For surgical instruments which are intended to interface with the Duo implant, the implant/instrument interface remains unchanged.
- The design changes included modifications to maintain or improve surgical instrument ergonomics and usability but do not alter the primary control mechanism or operating principle of the instrument.
- A risk assessment was performed and confirmed that the modifications to the Duo surgical instruments do not alter the risk profile for the device or present new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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August 14, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Spineology Inc. Karen Roche VP, Operations & Technology 7800 Third Street N., Suite 600 St. Paul, Minnesota 55128
Re: K181792
Trade/Device Name: Duo™ Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 25, 2018 Received: July 26, 2018
Dear Ms. Roche:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K181792
Device Name Duo™ Lumbar Interbody Fusion Device
Indications for Use (Describe)
The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be sketally mature and six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared: | July 3, 2018 |
|---|---|
| Submitter: | Spineology Inc. |
| 7800 3rd Street North | |
| Suite 600 | |
| Saint Paul, MN 55128 | |
| Establishment Registration Number: 2135156 | |
| Contact Person: | Karen Roche |
| Vice President, Operations and Technology | |
| Phone: 651.256.8513 | |
| Fax: 651.256.8505 | |
| Email: kroche@spineology.com | |
| Device Name and Classification | |
| Trade Names: | Duo™ Lumbar Interbody Fusion Device |
| Common Name: | Intervertebral body fusion device |
| Product Code: | MAX |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3080 |
Orthopedic Panel:
Predicate Device:
A. Device Description
The Duo™ Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum. The Duo implant is available in varying lengths and heights with two lordotic configurations, and is provided sterile. The device is designed with a porous central cavity for graft containment, rounded nose to aid implant insertion, and ridged teeth to resist migration.
B. Indications for Use
The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
C. Comparison to Predicate
When compared to the predicate device, the modified Duo System has the same or equivalent:
- Intended Use
- Indications for Use
- Fundamental Scientific Technology
- Principle of Operation
- Materials of Construction
- Risk Profile
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D. Non-Clinical Testing
Duo Surgical Instrumentation: Where applicable, verification testing was performed to support modifications to the Duo surgical instrumentation.
- . A review of the design changes to the Duo surgical instrumentation was performed and confirmed that these modifications do not present new technological characteristics or alter the intended use of these devices.
- For surgical instruments which are intended to interface with the Duo implant, the implant/instrument interface remains unchanged.
- The design changes included modifications to maintain or improve surgical instrument ergonomics and usability but do not alter the primary control mechanism or operating principle of the instrument.
- . A risk assessment was performed and confirmed that the modifications to the Duo surgical instruments do not alter the risk profile for the device or present new issues of safety or effectiveness.
ட். Conclusion
Based on individual and collective review of the modification to the Duo System, Spineology has demonstrated that the modified Duo System is substantially equivalent to the predicate device.